PHARMACEUTICAL – JR. CQV ENGINEER

MMR Consulting; Carlsbad (CA); On-site; USD 80,000 - 115,000; Full time

Job summary

MMR Consulting is seeking a Jr. CQV Engineer to join our engineering team in the pharmaceutical/biotech sectors. You will work on validation of upstream/downstream bioprocess systems and associated equipment, while developing leadership skills to guide intermediate and junior engineers.

Work will be performed at client sites—primarily in the Greater Denver/Boulder area—travel permitting. You will help design, start-up, qualification, and project management activities across processes and

Qualifications

• 2-4 years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry.
• Previous pharma/biotech experience with knowledge of cGMP requirements.
• Experience with validation project development and execution (IQ/OQ/PQ, FAT/SAT).
• Engineering degree in Mechanical, Electrical or Chemical.

Responsibilities

• Provide technical guidance in the commissioning, qualification and start-up of pharmaceutical/biopharmaceutical equipment, utilities and facilities.
• Lead the development of qualification deliverables such as DQ, FAT, SAT, IQ, OQ and PQ.
• Able to perform field execution of qualification test cases and protocols.
• Support development of Project Validation Plans (PVPs) to ensure the action plan is applicable and relevant.
• Lead qualification processes to ensure timely completion and compliance with specifications.
• Coordinate meetings with cross-functional departments to drive project progress and decisions.
• Travel occasionally for meetings with equipment fabrication vendors or FATs.
• Work may involve on-site client facilities and adherence to safety policies.

Skills

Technical leadership

Leadership

Problem solving

Communication

Multitasking

Safety compliance

Education

Engineering degree (Mechanical/Electrical/Chemical)

Tools

PCS

SCADA

Historians

Automation systems

Job description

MMRConsultingisanengineeringandconsultingfirmspecializinginthepharmaceuticalandbiotechnologyindustries.ItsservicesincludeEngineering,ProjectManagement,andValidation.

MMRConsultinghasofficesinCanada,USA,andAustralia.

Thisisanoutstandingopportunitytojoinourgrowingteam,wherethesuccessfulcandidatewillworkwithagroupofengineersinvolvedinthedesign,commissioning&qualification,start-upandprojectmanagementofvariousprocesses,systems,andfacilities.

ThisroleisforJr.CQVEngineerwillrequiretoworkonthevalidationofupstreamanddownstreambioprocesssystems/equipmentinthebiopharmaceuticalindustry,aswellasprocessequipmentinpharma/biotechindustries.Theidealcandidateshouldpossessleadershipskillstoleadteamsofintermediate&juniorengineers.

Theworkwillrequireworkingoutofclient’sfacilities,whicharetypicallyintheGreaterDenver/BoulderColorado&surroundingareas.

Responsibilities

• Providetechnicalguidanceinthecommissioning,qualificationandstart-upofvariouspharmaceutical/biopharmaceuticalcGMPprocessequipment,utilities&facilities.
• Leadthedevelopment(forexample,writetestcases)ofkeyqualificationdeliverablessuchasDQ,FAT,SAT,IQ,OQandPQduringtheprojectlifecycle.
• Abletoperformfieldexecutionofqualificationtestcasesandprotocols.
• SupportdevelopmentofProjectValidationPlans(PVPs)toensuretheactionplantotestthesystemisapplicableandrelevant.
• Leadqualificationprocessesthroughouttheprojectlifecycletoensuretimelycompletionandtoensureallqualityandengineeringspecificationsaremet.
• Possessknowledgeofrelevantregulatoryrequirementsandindustrybestpracticesonalloranyofthefollowing-Processequipment,cleanutilities,automationsystems,laboratoryequipment,building&facilities
• Coordinatemeetingswithcross-functionaldepartments,todriveprojectprogress,facilitatedecisions,andprovideupdates.
• Engageotherdepartments,asrequired,inthedesignreviewsanddecisions.
• TravelmaybeoccasionallyrequiredformeetingswithequipmentfabricationvendorsorFactoryAcceptanceTesting(FATs).
• Workmayrequireoccasionalsupportovershutdownsorextendedhours,specificallyduringinstallation,construction,commissioning,qualification,andvalidationphases.
• Visitconstructionandinstallationsites,wearingnecessarysafetyPPE.
• Youmaybeinvolvedwithotheraspectssuchasclient-management(maintainkeyClientrelationshipsinsupportofbusinessdevelopmentandpursuitofnewwork),projectscheduling/budgeting,coordinationofclientandMMRresourcesforeffectiveprojectdelivery,supportingbusinessdevelopment(providingtechnicalsupporttothesalesasrequiredforproposals/opportunities),presentingatindustryconferences/publishingpapersetc.
• Supervisecontractorsduringcriticaltestingofsystemandequipment.
• Otherdutiesasassignedbyclient,and/orMMR,basedonworkloadandprojectrequirements.
• Asthispositionrequiresworkingonclientsites,youwillneedtocomplywiththeclient’ssafetyrulesincludingmandatoryvaccinationpoliciesforCOVID-19,whereapplicable

Qualifications

• 2-4yearsofexperienceincommissioning,qualificationorvalidationofvarioussystemswithinthepharmaceutical/biotechindustry.
• Previousexperienceinthepharmaceutical/biotechindustry,withknowledgeofrequirementsforcGMPoperations.
• Validationexperiencesuchascleaningvalidation,thermalvalidation,mixingstudies,processvalidation,computersystemsvalidationisanassetbutnotrequired.
• ExperiencewithdevelopingandexecutingvalidationprojectstoRisk-BasedCommissioning&Qualificationapproaches,suchasASTME-2500orISPEICQ,isconsideredanasset,butnotrequired.
• Experiencewithcommissioning&qualificationofprocesscontrolsystems(i.e.PCS,SCADA,Historians)andbuildingautomationsystemsareconsideredanasset.
• Experiencewithcommissioningandqualificationsofbiotechprocessequipment,suchassome,butnotall,ofthefollowing:fermentation,bioreactors,downstreampurificationprocesses(chromatography,TFF,UF),CIPsystems,Buffersystems,CleanUtilitieswouldbeanasset.
• ExperiencewithQualificationorValidationofcleanutilitiesandISOcleanrooms.
• ExperiencewithpreparationandexecutionofURS’s,DQ’s,RTMs,RiskAssessments,CPPs,VPPs,FATs,SATs,IOQs
• Engineeringdegree,preferablyinMechanical,ElectricalorChemical.
• Travelmayberequiredonoccasion.
• Abilitytohandlemultipleprojectsandworkinafast-pacedenvironment.
• Strongmulti-taskingskills
• Abilitytolift50lbs.

Compensation:80,000$-115,000$basedonexperience.

Aspartofourrecruitmentprocess,wemayusetechnology-assistedtools,includingAI-enabledsystems,tosupportapplicationreviewandcandidateevaluation.Hiringdecisionsaremadewithhumanoversightandconsideration.

EqualEmploymentOpportunityandReasonableAccommodations

MMRConsultingisanequalopportunityemployer.Wecelebratediversityandarecommittedtocreatinganinclusiveenvironmentforallemployees.Ourhiringdecisionsarebasedonmerit,qualifications,andbusinessneeds.Wearecommittedtoworkingwithandprovidingreasonableaccommodationstoindividualswithdisabilitiesglobally.If,becauseofamedicalconditionordisability,youneedareasonableaccommodationforanypartoftheapplicationorinterviewprocess,pleaseletusknowthenatureofyourrequest.